Regulatory Affairs / Drug Safety Coordinator (m/f)

REFERENZNUMMER:

311442/11

IHRE AUFGABEN:

-Coordinate and submit marketing authorization, license renewal, product transfers and variation applications to Swissmedic
-Collaborate with the Regulatory Affairs team
-Generate and submit Periodic Safety Update Reports (PSURs / PBRERs) to Swissmedic
-Create and revise (safety) labelling material/product information of medicinal products in collaboration with Marketing, Corporate and the RA team
-Coordinate, prepare and submit clinical trial applications (including notification of changes) to Swissmedic and ethics committees
-Comply with national regulations and guidelines, legal, regulatory, quality (e.g. ISO, GxP) requirements and company policies
-Ensure high ethical conduct

IHRE QUALIFIKATIONEN:

-Degree in pharmacy, medicine, biology, biochemistry, chemistry or related disciplines
-Solid experience in Regulatory Affairs and/or Quality Assurance in a regulated industry (pharma or medical devices) or health care
-Solid experience in submissions to health authorities, preferably Swissmedic
-Knowledge of GxP, ISO 13485, MDD (as applicable) and local quality regulatory requirements
-Solid experience in leading people and cross-functional teams; project management
-Fluency in German and English, in both spoken and written form is a requirement

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager, Regulatory affairs assistant